Sex differences in clinical response to deep brain stimulation in resistant obsessive-compulsive disorder.

INTRODUCTION: Deep brain stimulation (DBS) is an effective alternative to treat severe refractory obsessive-compulsive disorder (OCD), although little is known on factors predicting response. The objective of this study was to explore potential sex differences in the pattern of response to DBS in OCD patients. METHODS: We conducted a prospective observational study in 25 patients with severe resistant OCD. Response to treatment was defined as a ≥35% reduction in Yale-Brown Obsessive Compulsive Scale (Y-BOCS) score. Logistic regression models were calculated to measure the likelihood of response at short and long-term follow-up by sex as measured by Y-BOCS score. Similar analyses were carried out to study changes in depressive symptomatology assessed with the Hamilton Depression Rating Scale (HDRS). Additionally, effect sizes were calculated to assess clinical significance. RESULTS: We did not observe significant clinical differences between men and women prior to DBS implantation, nor in the response after one year of stimulation. At long-term follow-up, 76.9% of men could be considered responders to DBS versus only 33.3% of women. The final response odds ratio in men was 10.05 with significant confidence intervals (88.90-1.14). No other predictors of response were identified. The sex difference in Y-BOCS reduction was clinically significant, with an effect size of 3.2. The main limitation was the small sample size. CONCLUSIONS: Our results suggest that gender could influence the long-term response to DBS in OCD, a finding that needs to be confirmed in new studies given the paucity of results on predictors of response to DBS.

GOIZ ZAINDU study: a FINGER-like multidomain lifestyle intervention feasibility randomized trial to prevent dementia in Southern Europe.

BACKGROUND: GOIZ ZAINDU ("caring early" in Basque) is a pilot study to adapt the Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) methodology to the Basque population and evaluate the feasibility and adherence to a FINGER-like multidomain intervention program. Additional aims included the assessment of efficacy on cognition and data collection to design a large efficacy trial. METHOD: GOIZ ZAINDU is a 1-year, randomized, controlled trial of a multidomain intervention in persons aged 60+ years, with Cardiovascular Risk Factors, Aging and Dementia (CAIDE) risk score ≥ 6, no diagnosis of dementia, and below-than-expected performance in at least one of three cognitive screening tests. Randomization to a multidomain intervention (MD-Int) or regular health advice (RHA) was stratified by sex, age (>/≤ 75), and cognitive status (mild cognitive impairment (MCI)/normal cognition). MD-Int included cardiovascular risk factor control, nutritional counseling, physical activity, and cognitive training. The primary outcomes were retention rate and adherence to the intervention program. Exploratory cognitive outcomes included changes in the Neuropsychological Test Battery z-scores. Analyses were performed according to the intention to treat. RESULTS: One hundred twenty-five participants were recruited (mean age: 75.64 (± 6.46); 58% women). The MD-Int (n = 61) and RHA (n = 64) groups were balanced in terms of their demographics and cognition. Fifty-two (85%) participants from the RHA group and 56 (88%) from the MD-Int group completed the study. More than 70% of the participants had high overall adherence to the intervention activities. The risk of cognitive decline was higher in the RHA group than in the MD-Int group in terms of executive function (p =.019) and processing speed scores (p =.026). CONCLUSIONS: The GOIZ-ZAINDU study proved that the FINGER methodology is adaptable and feasible in a different socio-cultural environment. The exploratory efficacy results showed a lower risk of decline in executive function and processing speed in the intervention group. These results support the design of a large-scale efficacy trial. TRIAL REGISTRATION: GOIZ ZAINDU feasibility trial was approved and registered by the Euskadi Drug Research Ethics Committee (ID: PI2017134) on 23 January 2018. Retrospectively registered in ClinicalTrials.gov (NCT06163716) on 8 December 2023.

Comorbidity and household income as mediators of gender inequalities in dementia risk: a real-world data population study.

BACKGROUND: Low household income (HI), comorbidities and female sex are associated with an increased risk of dementia. The aim of this study was to measure the mediating effect of comorbidity and HI on the excess risk due to gender in relation to the incidence and prevalence of dementia in the general population. METHODS: A retrospective and observational study using real-world data analysed all people over 60 who were registered with the Basque Health Service in Gipuzkoa. The study measured HI level, the Charlson comorbidity index (CCI), age and sex. The prevalence and incidence of dementia were analysed using logistic regression and Poisson regression models, respectively, adjusted by HI, sex, comorbidity and age. We estimated the combined mediation effect of HI and comorbidity on the prevalence of dementia associated with gender. RESULTS: Of the 221,777 individuals, 3.85% (8,549) had a diagnosis of dementia as of 31 December 2021. Classification by the CCI showed a gradient with 2.90% in CCI 0-1, 10.60% in CCI 2-3 and 18.01% in CCI > 3. Both low HI and gender were associated with a higher crude prevalence of dementia. However, in the CCI-adjusted model, women had an increased risk of dementia, while HI was no longer statistically significant. The incidence analysis produced similar results, although HI was not significant in any model. The CCI was significantly higher for men and for people with low HI. The mediation was statistically significant, and the CCI and HI explained 79% of the gender effect. CONCLUSIONS: Comorbidity and low HI act as mediators in the increased risk of dementia associated with female sex. Given the difference in the prevalence of comorbidities by HI, individual interventions to control comorbidities could not only prevent dementia but also reduce inequalities, as the risk is greater in the most disadvantaged population.

Using Age-Specific Rates for Parametric Survival Function Estimation in Simulation Models.

PURPOSE: To describe a procedure for incorporating parametric functions into individual-level simulation models to sample time to event when age-specific rates are available but not the individual data. METHODS: Using age-specific event rates, regression analysis was used to parametrize parametric survival distributions (Weibull, Gompertz, log-normal, and log-logistic), select the best fit using the R2 statistic, and apply the corresponding formula to assign random times to events in simulation models. We used stroke rates in the Spanish population to illustrate our procedure. RESULTS: The 3 selected survival functions (Gompertz, Weibull, and log-normal) had a good fit to the data up to 85 y of age. We selected Gompertz distribution as the best-fitting distribution due to its goodness of fit. CONCLUSIONS: Our work provides a simple procedure for incorporating parametric risk functions into simulation models without individual-level data. HIGHLIGHTS: We describe the procedure for sampling times to event for individual-level simulation models as a function of age from parametric survival functions when age-specific rates are available but not the individual dataWe used linear regression to estimate age-specific hazard functions, obtaining estimates of parameter uncertainty.Our approach allows incorporating parameter (second-order) uncertainty in individual-level simulation models needed for probabilistic sensitivity analysis in the absence of individual-level survival data.

Cost-Effectiveness Analysis of Vaccines for COVID-19 According to Sex, Comorbidity and Socioeconomic Status: A Population Study.

BACKGROUND AND OBJECTIVE: Coronavirus disease 2019 (COVID-19) vaccines are extremely effective in preventing severe disease, but their real-world cost effectiveness is still an open question. We present an analysis of the cost-effectiveness and economic impact of the initial phase of the COVID-19 vaccination rollout in the Basque Country, Spain. METHODS: To calculate costs and quality-adjusted life years for the entire population of the Basque Country, dynamic modelling and a real-world data analysis were combined. Data on COVID-19 infection outcomes (cases, hospitalisations, intensive care unit admissions and deaths) and population characteristics (age, sex, socioeconomic status and comorbidity) during the initial phase of the vaccination rollout, from January to June of 2021, were retrieved from the Basque Health Service database. The outcomes in the alternative scenario (without vaccination) were estimated with the dynamic model used to guide public health authority policies, from February to December 2020. Individual comorbidity-adjusted life expectancy and costs were estimated. RESULTS: By averting severe disease-related outcomes, COVID-19 vaccination resulted in monetary savings of €26.44 million for the first semester of 2021. The incremental cost-effectiveness ratio was €707/quality-adjusted life year considering official vaccine prices and dominant real prices. While the analysis by comorbidity showed that vaccines were considerably more cost effective in individuals with pre-existing health conditions, this benefit was lower in the low socioeconomic status group. CONCLUSIONS: The incremental cost-effectiveness ratio of the vaccination programme justified the policy of prioritising high-comorbidity patients. The initial phase of COVID-19 vaccination was dominant from the perspective of the healthcare payer.

The effect of mixed vaccination rollout strategy: A modelling study.

Vaccines have measurable efficacy obtained first from vaccine trials. However, vaccine efficacy (VE) is not a static measure and long-term population studies are needed to evaluate its performance and impact. COVID-19 vaccines have been developed in record time and the currently licensed vaccines are extremely effective against severe disease with higher VE after the full immunization schedule. To assess the impact of the initial phase of the COVID-19 vaccination rollout programmes, we used an extended Susceptible - Hospitalized - Asymptomatic/mild - Recovered (SHAR) model. Vaccination models were proposed to evaluate different vaccine types: vaccine type 1 which protects against severe disease only but fails to block disease transmission, and vaccine type 2 which protects against both severe disease and infection. VE was assumed as reported by the vaccine trials incorporating the difference in efficacy between one and two doses of vaccine administration. We described the performance of the vaccine in reducing hospitalizations during a momentary scenario in the Basque Country, Spain. With a population in a mixed vaccination setting, our results have shown that reductions in hospitalized COVID-19 cases were observed five months after the vaccination rollout started, from May to June 2021. Specifically in June, a good agreement between modelling simulation and empirical data was well pronounced.

Cost-utility analysis of the UPRIGHT intervention promoting resilience in adolescents.

BACKGROUND: As mental health in adulthood is related to mental status during adolescence, school-based interventions have been proposed to improve resilience. The objective of this study was to build a simulation model representing the natural history of mental disorders in childhood, adolescence and youth to estimate the cost-effectiveness of the UPRIGHT school-based intervention in promoting resilience and mental health in adolescence. METHODS: We built a discrete event simulation model fed with real-world data (cumulative incidence disaggregated into eight clusters) from the Basque Health Service database (609,381 individuals) to calculate utilities (quality-adjusted life years [QALYs]) and costs for the general population in two scenarios (base case and intervention). The model translated changes in the wellbeing of adolescents into different risks of mental illnesses for a time horizon of 30 years. RESULTS: The number of cases of anxiety was estimated to fall by 5,125 or 9,592 and those of depression by 1,269 and 2,165 if the effect of the intervention lasted 2 or 5 years respectively. From a healthcare system perspective, the intervention was cost-effective for all cases considered with incremental cost-utility ratios always lower than €10,000/QALY and dominant for some subgroups. The intervention was always dominant when including indirect and non-medical costs (societal perspective). CONCLUSIONS: Although the primary analysis of the trial did not did not detect significant differences, the UPRIGHT intervention promoting positive mental health was dominant in the economic evaluation from the societal perspective. Promoting resilience was more cost-effective in the most deprived group. Despite a lack of information about the spillover effect in some sectors, the economic evaluation framework developed principally for pharmacoeconomics can be applied to interventions to promote resilience in adolescents. As prevention of mental health disorders is even more necessary in the post-coronavirus disease-19 era, such evaluation is essential to assess whether investment in mental health promotion would be good value for money by avoiding costs for healthcare providers and other stakeholders.

Excess healthcare costs of mental disorders in children, adolescents and young adults in the Basque population registry adjusted for socioeconomic status and sex.

BACKGROUND: Mental illnesses account for a considerable proportion of the global burden of disease. Economic evaluation of public policies and interventions aimed at mental health is crucial to inform decisions and improve the provision of healthcare services, but experts highlight that nowadays the cost implications of mental illness are not properly quantified. The objective was to measure the costs of excess use of all healthcare services by 1- to 30-year-olds in the Basque population as a function of whether or not they had a mental disorder diagnosis. METHODS: A real-world data study was used to identify diagnoses of mental disorders and to measure resource use in the Basque Health Service Registry in 2018. Diagnoses were aggregated into eight diagnostic clusters: anxiety, attention deficit hyperactivity disorder, conduct disorders, mood disorders, substance use, psychosis and personality disorders, eating disorders, and self-harm. We calculated the costs incurred by each individual by multiplying the resource use by the unit costs. Annual costs for each cluster were compared with those for individuals with no diagnosed mental disorders through entropy balancing and two-part models which adjusted for socioeconomic status (SES). RESULTS: Of the 609,381 individuals included, 96,671 (15.9%) had ≥ 1 mental disorder diagnosis. The annual cost per person was two-fold higher in the group diagnosed with mental disorders (€699.7) than that with no diagnoses (€274.6). For all clusters, annual excess costs associated with mental disorders were significant. The adjustment also evidenced a social gradient in healthcare costs, individuals with lower SES consuming more resources than those with medium and higher SES across all clusters. Nonetheless, the effect of being diagnosed with a mental disorder had a greater impact on the mean and excess costs than SES. CONCLUSIONS: Results were consistent in showing that young people with mental disorders place a greater burden on healthcare services. Excess costs were higher for severe mental disorders like self-harm and psychoses, and lower SES individuals incurred, overall, more than twice the costs per person with no diagnoses. A socioeconomic gradient was notable, excess costs being higher in low SES individuals than those with a high-to-medium SES. Differences by sex were also statistically significant but their sizes were smaller than those related to SES.

[Cost-effectiveness of universal childhood vaccination against hepatitis A in Spain: a dynamic approach]. / Coste-efectividad de la vacunación universal infantil frente a la hepatitis A en España: un enfoque dinámico.

OBJECTIVE: To evaluate the cost-effectiveness of infant universal vaccination against hepatitis A in Spain. METHOD: Using a dynamic model and decision tree model, a cost-effectiveness analysis was performed to compare three vaccination strategies against hepatitis A: non-vaccination strategy versus universal childhood vaccination of hepatitis A with one or two doses. The perspective of the study was that of the National Health System (NHS) and a lifetime horizon was considered. Both costs and effects were discounted at 3% per year. Health outcomes were measured in terms of quality adjusted life years (QALY) and the cost-effectiveness measure used was the incremental cost-effectiveness ratio (ICER). In addition, deterministic sensitivity analysis by scenarios was performed. RESULTS: In the particular case of Spain, with low endemicity for hepatitis A, the difference in health outcomes between vaccination strategies (with 1 or 2 doses) and non-vaccination are practically non-existent, terms of QALY. In addition, the ICER obtained is high, exceeding the limits of willingness to pay from Spain (€22,000-25,000/QALY). The deterministic sensitivity analysis showed that the results are sensitive to the variations of the key parameters, although in no case the vaccination strategies are cost-effective. CONCLUSIONS: Universal infant vaccination strategy against hepatitis A would not be a cost-effective option from the NHS perspective in Spain.

Assessment of the Effectiveness, Socio-Economic Impact and Implementation of a Digital Solution for Patients with Advanced Chronic Diseases: The ADLIFE Study Protocol.

Due to population ageing and medical advances, people with advanced chronic diseases (ACD) live longer. Such patients are even more likely to face either temporary or permanent reduced functional reserve, which typically further increases their healthcare resource use and the burden of care on their caregiver(s). Accordingly, these patients and their caregiver(s) may benefit from integrated supportive care provided via digitally supported interventions. This approach may either maintain or improve their quality of life, increase their independence, and optimize the healthcare resource use from early stages. ADLIFE is an EU-funded project, aiming to improve the quality of life of older people with ACD by providing integrated personalized care via a digitally enabled toolbox. Indeed, the ADLIFE toolbox is a digital solution which provides patients, caregivers, and health professionals with digitally enabled, integrated, and personalized care, supporting clinical decisions, and encouraging independence and self-management. Here we present the protocol of the ADLIFE study, which is designed to provide robust scientific evidence on the assessment of the effectiveness, socio-economic, implementation, and technology acceptance aspects of the ADLIFE intervention compared to the current standard of care (SoC) when applied in real-life settings of seven different pilot sites across six countries. A quasi-experimental trial following a multicenter, non-randomized, non-concurrent, unblinded, and controlled design will be implemented. Patients in the intervention group will receive the ADLIFE intervention, while patients in the control group will receive SoC. The assessment of the ADLIFE intervention will be conducted using a mixed-methods approach.

Incidence of mental disorders in the general population aged 1-30 years disaggregated by gender and socioeconomic status.

PURPOSE: The objective of this study was to estimate the incidence and age of onset of mental disorders diagnosed by gender and socioeconomic status (SES) in children, adolescents, and young adults up to 30 years of age in the whole population of the Basque Country (Spain). METHODS: All mental health diagnoses documented in Basque Health Service records from 1 January 2003 to 31 December 2018, were classified into eight clusters: anxiety, attention deficit hyperactivity disorder (ADHD), conduct disorders, depression, psychosis/personality disorders, substance use, eating disorders, and self-harm. We calculated incidence and cumulative incidence for each cluster, disaggregated by gender, and socioeconomic status (SES). Poisson regression analyses were performed. RESULTS: Overall, 9,486,853 person-years of observation were available for the 609,281 individuals included. ADHD and conduct disorders were diagnosed in the first decade, anxiety and depression disorders in the second and third decades, and psychosis/personality and substance use in the third. The cumulative incidence at 18 years of age for any type of disorder was 15.5%. The group with low SES had a statistically significantly higher incidence of all eight clusters. The incidence of ADHD, conduct disorders, depression, psychosis/personality disorders, and substance use was higher in males and that of anxiety, eating disorders and self-harm was higher in females. CONCLUSIONS: The incidence of mental disorders is high among children, adolescents, and young adults in the Basque Country underlining the need for preventive interventions. Marked differences by gender and SES highlight mental health inequalities, especially for depression and psychosis in low SES males.

Cost-effectiveness models for Alzheimer's disease and related dementias: IPECAD modeling workshop cross-comparison challenge.

INTRODUCTION: The credibility of model-based economic evaluations of Alzheimer's disease (AD) interventions is central to appropriate decision-making in a policy context. We report on the International PharmacoEconomic Collaboration on Alzheimer's Disease (IPECAD) Modeling Workshop Challenge. METHODS: Two common benchmark scenarios, for the hypothetical treatment of AD mild cognitive impairment (MCI) and mild dementia, were developed jointly by 29 participants. Model outcomes were summarized, and cross-comparisons were discussed during a structured workshop. RESULTS: A broad concordance was established among participants. Mean 10-year restricted survival and time in MCI in the control group ranged across 10 MCI models from 6.7 to 9.5 years and 3.4 to 5.6 years, respectively; and across 4 mild dementia models from 5.4 to 7.9 years (survival) and 1.5 to 4.2 years (mild dementia). DISCUSSION: The model comparison increased our understanding of methods, data used, and disease progression. We established a collaboration framework to assess cost-effectiveness outcomes, an important step toward transparent and credible AD models.

Coste-efectividad de la vacunación universal infantil frente a la hepatitis A en España: un enfoque dinámico / Cost-effectiveness of universal childhood vaccination against hepatitis A in Spain: a dynamic approach

Objetivo: Evaluar el coste-efectividad de diferentes estrategias de vacunación universal infantil frente a la hepatitis A en España. Método: A partir de un modelo dinámico y un árbol de decisión, se realizó un análisis de coste-efectividad para comparar tres estrategias de vacunación frente a la hepatitis A: no vacunación y vacunación universal infantil con una y dos dosis. La perspectiva del estudio escogida fue la del Sistema Nacional de Salud (SNS) y se consideró como horizonte temporal toda la vida del paciente. Tanto los costes como los efectos se descontaron al 3% anual. Los resultados en salud se midieron en años de vida ajustados por calidad (AVAC) y la medida de coste-efectividad utilizada es la razón de coste-efectividad incremental (RCEI). Además, se llevaron a cabo análisis de sensibilidad determinísticos por escenarios. Resultados: En el caso particular de España, con baja endemicidad de hepatitis A, las diferencias en resultados en salud entre las distintas estrategias de vacunación (con una o dos dosis) y la no vacunación son prácticamente inexistentes, en términos de AVAC. Además, las RCEI obtenidas son elevadas, superando los límites establecidos de disposición a pagar obtenidos en España (22.000-25.000 €/AVAC). El análisis de sensibilidad determinístico muestra que los resultados son sensibles a las variaciones de los parámetros clave, aunque en ningún caso resultan coste-efectivos. Conclusiones: La vacunación universal infantil frente a la hepatitis A no sería una opción coste-efectiva desde la perspectiva del SNS en España en la actualidad. (AU)

Objective: To evaluate the cost-effectiveness of infant universal vaccination against hepatitis A in Spain. Method: Using a dynamic model and decision tree model, a cost-effectiveness analysis was performed to compare three vaccination strategies against hepatitis A: non-vaccination strategy versus universal childhood vaccination of hepatitis A with one or two doses. The perspective of the study was that of the National Health System (NHS) and a lifetime horizon was considered. Both costs and effects were discounted at 3% per year. Health outcomes were measured in terms of quality adjusted life years (QALY) and the cost-effectiveness measure used was the incremental cost-effectiveness ratio (ICER). In addition, deterministic sensitivity analysis by scenarios was performed. Results: In the particular case of Spain, with low endemicity for hepatitis A, the difference in health outcomes between vaccination strategies (with 1 or 2 doses) and non-vaccination are practically non-existent, terms of QALY. In addition, the ICER obtained is high, exceeding the limits of willingness to pay from Spain (€22,000–25,000/QALY). The deterministic sensitivity analysis showed that the results are sensitive to the variations of the key parameters, although in no case the vaccination strategies are cost-effective. Conclusions: Universal infant vaccination strategy against hepatitis A would not be a cost-effective option from the NHS perspective in Spain. (AU)

Budget impact analysis of the use of Souvenaid in patients with prodromal Alzheimer's Disease in Spain.

INTRODUCTION: The effectiveness, safety, and cost-effectiveness of the use of Souvenaid for Alzheimer's disease (AD) have been previously evidenced. To complete the economic analysis, there is a need to assess whether society can afford it. The objective of this study was to carry out a budget impact analysis of the use of Souvenaid in Spain under the conditions of the LipiDidiet clinical trial from a societal perspective. METHODS: We built a population model that took into account all the cohorts of individuals with AD, their individual progression, and the potential impact of Souvenaid treatment on their trajectories. Patient progression data were obtained from mixed models. The target population was estimated based on the population forecast for 2020-2035 and the incidence of dementia. Individual progression to dementia measured by the Clinical Dementia Rating-Sum of Boxes was reproduced using mixed models. Besides the costs of treatment and diagnosis, direct costs of medical and non-medical care and indirect costs were included. RESULTS: The epidemiological indicators and the distribution of life expectancy by stages validated the model. From the third year (2022), the differences in the cost of dementia offset the incremental cost of diagnosis and treatment. The costs of dependency reached €500 million/year while those of the intervention were limited to €40 million. CONCLUSIONS: Souvenaid, with modest effectiveness in delaying dementia associated with AD, achieved a positive economic balance between costs and savings. Its use in the treatment of prodromal AD would imply an initial cost that would be ongoing, but this would be offset by savings in the care system for dependency associated with dementia from the third year. These results were based on adopting a societal perspective taking into account the effect of treatment on the use of health, social, and family resources.

Changes in Social and Clinical Determinants of COVID-19 Outcomes Achieved by the Vaccination Program: A Nationwide Cohort Study.

BACKGROUND: The objective of this study was to assess changes in social and clinical determinants of COVID-19 outcomes associated with the first year of COVID-19 vaccination rollout in the Basque population. METHODS: A retrospective study was performed using the complete database of the Basque Health Service (n = 2,343,858). We analyzed data on age, sex, socioeconomic status, the Charlson comorbidity index (CCI), hospitalization and intensive care unit (ICU) admission, and COVID-19 infection by Cox regression models and Kaplan-Meier curves. RESULTS: Women had a higher hazard ratio (HR) of infection (1.1) and a much lower rate of hospitalization (0.7). With older age, the risk of infection fell, but the risks of hospitalization and ICU admission increased. The higher the CCI, the higher the risks of infection and hospitalization. The risk of infection was higher in high-income individuals in all periods (HR = 1.2-1.4) while their risk of hospitalization was lower in the post-vaccination period (HR = 0.451). CONCLUSION: Despite the lifting of many control measures during the second half of 2021, restoring human mobility patterns, the situation could not be defined as syndemic, clinical determinants seeming to have more influence than social ones on COVID-19 outcomes, both before and after vaccination program implementation.

Estimation of the epidemiology of dementia and associated neuropsychiatric symptoms by applying machine learning to real-world data.

INTRODUCTION: Incidence rates of dementia-related neuropsychiatric symptoms (NPS) are not known and this hampers the assessment of their population burden. The objective of this study was to obtain an approximate estimate of the population incidence and prevalence of both dementia and NPS. METHODS: Given the dynamic nature of the population with dementia, a retrospective study was conducted within the database of the Basque Health Service (real-world data) at the beginning and end of 2019. Validated random forest models were used to identify separately depressive and psychotic clusters according to their presence in the electronic health records of all patients diagnosed with dementia. RESULTS: Among the 631,949 individuals over 60 years registered, 28,563 were diagnosed with dementia, of whom 15,828 (55.4%) showed psychotic symptoms and 19,461 (68.1%) depressive symptoms. The incidence of dementia in 2019 was 6.8/1000 person-years. Most incident cases of depressive (72.3%) and psychotic (51.9%) NPS occurred in cases of incident dementia. The risk of depressive-type NPS grows with years since dementia diagnosis, living in a nursing home, and female sex, but falls with older age. In the psychotic cluster model, the effects of male sex, and older age are inverted, both increasing the probability of this type of symptoms. CONCLUSIONS: The stigmatization factor conditions the social and attitudinal environment, delaying the diagnosis of dementia, preventing patients from receiving adequate care and exacerbating families' suffering. This study evidences the synergy between big data and real-world data for psychiatric epidemiological research.

Long-term comparative effectiveness of deep brain stimulation in severe obsessive-compulsive disorder.

BACKGROUND: Twenty years after the first use of Deep Brain Stimulation (DBS) in obsessive-compulsive disorder (OCD), our knowledge of the long-term effects of this therapeutic option remains very limited. OBJECTIVE: Our study aims to assess the long-term effectiveness and tolerability of DBS in OCD patients and to look for possible predictors of long-term response to this treatment. METHODS: We studied the course of 25 patients with severe refractory OCD treated with DBS over an average follow-up period of 6.4 years (±3.2) and compared them with a control group of 25 patients with severe OCD who refused DBS and maintained their usual treatment. DBS was implanted at the ventral anterior limb of the internal capsule and nucleus accumbens (vALIC-Nacc) in the first six patients and later at the bed nucleus of stria terminalis (BNST) in the rest of patients. Main outcome was change in Yale-Brown Obsessive-Compulsive Scale (Y-BOCS) score between the two groups assessed using mixed models. Secondary effectiveness outcomes included Hamilton Depression Rating Scale (HDRS) and Global Assessment of Functioning (GAF) scores. RESULTS: Obsessive symptoms fell by 42.5% (Y-BOCS score) in patients treated with DBS and by 4.8% in the control group. Fifty-six per cent of DBS-treated patients could be considered responders at the end of follow-up and 28% partial responders. Two patients among those who rejected DBS were partial responders (8%), but none of the non-DBS group achieved criteria for complete response. HDRS and GAF scores improved significantly in 39.2% and 43.6% among DBS-treated patients, while did not significantly change in those who rejected DBS (improvement limited to 6.2% in HDRS and 4.2% in GAF scores). No statistically significant predictors of response were found. Mixed models presented very large comparative effect sizes for DBS (4.29 for Y-BOCS, 1.15 for HDRS and 2.54 for GAF). Few patients experienced adverse effects and most of these effects were mild and transitory. CONCLUSIONS: The long-term comparative effectiveness and safety of DBS confirm it as a valid option for the treatment of severe refractory OCD.